Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Combination product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination product: Placebo

Detailed Description

As per the recommendation from Center for Biologics Evaluation and Research (CBER) the study has been amended to include a new "agar-overlay" serum bactericidal assay using human serum complement (hSBA). Additional changes include validation of the MenB manual to measure immunogenicity of the meningococcal group B vaccine, a modification in the definition of 4-fold increase in post-vaccination hSBA titer definition when the pre-vaccination titer is below the limit of detection, and a modification in the population set to be used for safety analysis wherein the exposed set is to be used for all safety analyses.

• Study Type: Interventional
• Enrollment (Actual): 945
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Chiavari GE, Italy, 16043
    • GSK Investigational Site
  • Foggia, Italy, 71122
    • GSK Investigational Site
  • Milano, Italy, 20122
    • GSK Investigational Site
  • Milano, Italy, 20162
    • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85238
      • GSK Investigational Site
  • California
    • Bell Gardens, California, United States, 90201
      • GSK Investigational Site
    • Los Angeles, California, United States, 90027
      • GSK Investigational Site
    • Oakland, California, United States, 94611
      • GSK Investigational Site
    • Roseville, California, United States, 95661
      • GSK Investigational Site
    • Sacramento, California, United States, 95815
      • GSK Investigational Site
    • San Jose, California, United States, 95119
      • GSK Investigational Site
    • Santa Clara, California, United States, 95051
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94596
      • GSK Investigational Site
  • Florida
    • Wellington, Florida, United States, 33470
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83702
      • GSK Investigational Site
    • Nampa, Idaho, United States, 83686
      • GSK Investigational Site
    • Nampa, Idaho, United States, 83687
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47715
      • GSK Investigational Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40291
      • GSK Investigational Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • GSK Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • GSK Investigational Site
    • Lincoln, Nebraska, United States, 68526
      • GSK Investigational Site
    • Lincoln, Nebraska, United States, 68516
      • GSK Investigational Site
    • Lincoln, Nebraska, United States, 68504
      • GSK Investigational Site
  • New York
    • Cortland, New York, United States, 13045
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28226
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • GSK Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • GSK Investigational Site
    • Hermitage, Pennsylvania, United States, 16148
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15217
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15025
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15234
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • GSK Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78726
      • GSK Investigational Site
    • Austin, Texas, United States, 75010
      • GSK Investigational Site
    • Austin, Texas, United States, 78613
      • GSK Investigational Site
    • Dallas, Texas, United States, 75251
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230-2571
      • GSK Investigational Site
    • Houston, Texas, United States, 77584
      • GSK Investigational Site
    • Plano, Texas, United States, 75093
      • GSK Investigational Site
    • Plano, Texas, United States, 75024
      • GSK Investigational Site
    • Victoria, Texas, United States, 77901
      • GSK Investigational Site
    • Waxahachie, Texas, United States, 75165
      • GSK Investigational Site
  • Utah
    • Orem, Utah, United States, 84057
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84107
      • GSK Investigational Site
    • South Jordan, Utah, United States, 84095
      • GSK Investigational Site
    • Syracuse, Utah, United States, 84075
      • GSK Investigational Site
  • Virginia
    • Falls Church, Virginia, United States, 22044
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23294
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
• Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
• Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
• A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
• Healthy participants as established by medical history and clinical examination before entering the study.
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

• Female participants of childbearing potential may be enrolled in the study if the participant:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Medical conditions

• Progressive, unstable, or uncontrolled clinical conditions.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

• Abnormal function of the immune system resulting from:

  • Clinical conditions.
  • Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
• Current or previous, confirmed, or suspected disease caused by N. meningitidis.
• Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
• History of neuroinflammatory or autoimmune condition.
• Recurrent history or un-controlled neurological disorders or seizures.

Prior/Concomitant therapy

• Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period.
• Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
• Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo, Menactra or MenQuadfi).

Prior/Concurrent clinical study experience

• Participant concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product, will not be enrolled.

Other exclusions

• Child in care.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any study personnel or immediate dependents, family, or household member.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenB+MenACWY Group; Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	Combination product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); 1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.; Other Names: Bexsero; Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); 1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.; Other Names: Menveo; Combination product: Placebo; 1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.; Other Names: NaCl, saline solution
Experimental: MenB Group; Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	Combination product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); 1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.; Other Names: Bexsero; Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); 1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.; Other Names: Menveo; Combination product: Placebo; 1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.; Other Names: NaCl, saline solution
Experimental: MenACWY Group; Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.	Combination product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); 1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.; Other Names: Bexsero; Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); 1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.; Other Names: Menveo; Combination product: Placebo; 1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.; Other Names: NaCl, saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.	During 7 days after the rMenB+OMV NZ vaccination at Day 1
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.	During 7 days after the rMenB+OMV NZ vaccination at Day 61
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.	During 7 days after the rMenB+OMV NZ vaccination at Day 91
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.	During 7 days after the MenACWY vaccination at Day 1
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.	During 7 days after the MenACWY vaccination at Day 61
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.	During 7 days after the MenACWY vaccination at Day 91
Number of Participants With Solicited Local AEs After the Vaccination With Placebo	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.	During 7 days after the Placebo vaccination at Day 1
Number of Participants With Solicited Local AEs After the Vaccination With Placebo	Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.	During 7 days after the Placebo vaccination at Day 91
Number of Participants With Solicited Systemic AEs	Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.	During 7 days after the first study intervention administration occurring at Day 1
Number of Participants With Solicited Systemic AEs	Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.	During 7 days after the second study intervention administration occurring at Day 61
Number of Participants With Solicited Systemic AEs	Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.	During 7 days after the third study intervention administration occurring at Day 91
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.	During 30 days after the first study intervention administration occurring at Day 1
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.	During 30 days after the second study intervention administration occurring at Day 61
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.	During 30 days after the third study intervention administration occurring at Day 91
Number of Participants With Any AEs/SAEs Leading to Withdrawal	Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.	During 30 days after the first study intervention administration occurring at Day 1
Number of Participants With Any AEs/SAEs Leading to Withdrawal	Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.	During 30 days after the second study intervention administration occurring at Day 61
Number of Participants With Any AEs/SAEs Leading to Withdrawal	Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.	During 30 days after the third study intervention administration occurring at Day 91
Number of Participants With Any Medically Attended AEs	Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.	During 30 days after the first study intervention administration occurring at Day 1
Number of Participants With Any Medically Attended AEs	Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.	During 30 days after the second study intervention administration occurring at Day 61
Number of Participants With Any Medically Attended AEs	Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.	During 30 days after the third study intervention administration occurring at Day 91
Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs	SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure.	Throughout the study period (Day 1 to Day 271)
Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)	AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.	Throughout the study period (Day 1 to Day 271)
Number of Participants With Any SAEs and AEs Leading to Withdrawal	Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.	During safety follow-up (Day 271 to Day 451)
Number of Participants Who Received rMenB+OMV NZ With AESI	AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.	During safety follow-up (Day 271 to Day 451)
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios	hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).	At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios	hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y.	At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination	Immune response to MenACWY given with or without rMenB+OMV NZ, as measured by ectrochemiluminescence-based multiplex (ECL) GMCs against each of the serogroups A, C, W and Y. ECL (validated assay) was used because ELISA is not validated.	At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios	hSBA titers were measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) and expressed in GMTs.	At Day 31 (1 month after first vaccination with rMenB+OMV NZ)
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination	The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline).	At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination	The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline).	At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination	The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).	At Day 31 (one month after the first rMenB+OMV NZ vaccination)
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination	The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).	At Day 91 (1 month after the second rMenB+OMV NZ vaccination)
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination	The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >= LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.	At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination	The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >=LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.	At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1)
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination	The immune response to MenACWY vaccines is expressed in terms of percentage of participants with hSBA titers >=LLOQ for each of the serogroup Men A, Men C, Men W and Men Y.	At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31)
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination	Immune response to MenACWY given with or without rMenB+OMV NZ was measured by bactericidal activity against the four serogroups Men A, Men C, Men W and Men Y in terms of GMRs at one month after MenACWY vaccination compared to the baseline at Day 1/Month 0. GMR was measured within-group.	At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1)
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination	The immune response to MenACWY vaccine is evaluated by measuring percentage of participants with 4-fold increase for the four serogroups Men A, Men C, Men W and Men Y. The Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer	At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): November 21, 2023
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Meningitis; Bexsero; Menveo; Invasive meningococcal disease
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Neisseriaceae Infections; Meningococcal Infections; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: 205419; 2016-003722-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes